Knee OsteoarthritisPhase 2NCT05839535
Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
A Phase 2 study testing BDJ, tDCS and exercise in people with Knee Osteoarthritis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BDJ, tDCS and exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers 45-75 years of age
- Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
- Physically able to participate in the BDJ and stretching control education programs
- Willing to complete the 12-week study
- Can participate in MRI scan
- Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures
Who cannot join
- Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
- Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
- Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
- Patient Mini-Mental Status Examination score below 24 [293]
- Unable to walk without a cane or other assistive device
- The intent to undergo surgery during the time of involvement in the study
- Plan to permanently relocate from the region during the trial period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
meixuan Zhu, 617-726-5004, mzhu11@mgh.harvard.edu
About this study
Official title: Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.
- Conditions
- Knee Osteoarthritis
- Being tested
- BDJ, tDCS, sham tDCS, exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDJBehavioural
BDJ is a mind-body intervention
tDCSDevice
tDCS is a brain stimulation method.
sham tDCSDevice
sham tDCS
exerciseOther
exercise including stretching and other activities.
| Study group | Role | What they receive |
|---|---|---|
| BDJ + real tDCS | Active comparator | Not described Receives: Behavioral: BDJ; Device: tDCS |
| Exercise + real tDCS | Active comparator | Not described Receives: Device: tDCS; Other: exercise |
| BDJ + sham tDCS | Active comparator | Not described Receives: Behavioral: BDJ; Device: sham tDCS |
| Exercise + sham tDCS | Active comparator | Not described Receives: Device: sham tDCS; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
M1 resting state functional connectivity
Changes in brain resting-state connectivity between the primary motor cortex (M1) and other brain regions pre- and post-treatments, analyzed using the CONN Toolbox (https://web.conn-toolbox.org/)
Measured: Baseline, post-treatment (12 weeks)
Secondary outcomes (9)
Change on Cerebral blood flow
Cerebral blood flow will be measured using arterial spin labeling (ASL)
Measured: Baseline, post-treatment (12 weeks)
Change on M1 corticospinal excitability and cortico-cortical excitability
M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).
Measured: Baseline, post-treatment (12 weeks)
Change on brain gray matter volume
Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.
Measured: Baseline, post-treatment (12 weeks)
Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a 35-item self-administered survey of pain and function in knee OA patients.
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29
We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days.
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
change on Beck's Depression Inventory (BDI-II)
BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression.
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Pain Catastrophizing Scale (PCS)
PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain.
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Quantitative Sensory Testing (QST)
Pressure pain thresholds will be assessed 3 times using a Somedic digital pressure algometer. Contact heat stimuli will be delivered using a PATHWAY CHEPS (Contact Heat-Evoked Potential Stimulator, Medoc Advanced Medical Systems).
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on 6-Minute Walk Test
The 6-Minute Walk Test is a self-paced endurance test that assesses walking ability and endurance and includes standardized encouragement that increase tolerability in elders and those with physical impairment.
Measured: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Mar 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical mechanism study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839535
- Sponsor's protocol ID
- 2023P000908
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05839535
- Acronym / sponsor ID
- 2023P000908
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Clinical mechanism study
| Arm | Type | Receives |
|---|---|---|
| BDJ + real tDCS | Active comparator | Behavioral: BDJ, Device: tDCS |
| Exercise + real tDCS | Active comparator | Device: tDCS, Other: exercise |
| BDJ + sham tDCS | Active comparator | Behavioral: BDJ, Device: sham tDCS |
| Exercise + sham tDCS | Active comparator | Device: sham tDCS, Other: exercise |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers 45-75 years of age
- Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
- Physically able to participate in the BDJ and stretching control education programs
- Willing to complete the 12-week study
- Can participate in MRI scan
Key exclusion criteria (7 listed)
- Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
- Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
- Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
- Patient Mini-Mental Status Examination score below 24 [293]
- Unable to walk without a cane or other assistive device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDJBDJ is a mind-body intervention | Behavioural | BDJ + real tDCS, BDJ + sham tDCS |
| tDCStDCS is a brain stimulation method. | Device | BDJ + real tDCS, Exercise + real tDCS |
| sham tDCSsham tDCS | Device | BDJ + sham tDCS, Exercise + sham tDCS |
| exerciseexercise including stretching and other activities. | Other | Exercise + real tDCS, Exercise + sham tDCS |
Primary outcome
M1 resting state functional connectivity
Time frame: Baseline, post-treatment (12 weeks)
Changes in brain resting-state connectivity between the primary motor cortex (M1) and other brain regions pre- and post-treatments, analyzed using the CONN Toolbox (https://web.conn-toolbox.org/)
9 secondary outcomes
Change on Cerebral blood flow
Time frame: Baseline, post-treatment (12 weeks)
Change on M1 corticospinal excitability and cortico-cortical excitability
Time frame: Baseline, post-treatment (12 weeks)
Change on brain gray matter volume
Time frame: Baseline, post-treatment (12 weeks)
Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
change on Beck's Depression Inventory (BDI-II)
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Pain Catastrophizing Scale (PCS)
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Quantitative Sensory Testing (QST)
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on 6-Minute Walk Test
Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BDJ, tDCS and exercise in people with Knee Osteoarthritis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Kong (617-7267893, jkong2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M1 resting state functional connectivity (time frame: Baseline, post-treatment (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.